OTC Medicines

Since the Final Rule was published in 1995, FDA has received six Citizen Petitions (CPs) requesting the addition of alternatives to the animal caries test to the Anticaries Monograph.

Dextromethorphan serves as a safe, effective antitussive ingredient in many critical OTC cough and cold formulations. While reasonable age restrictions may curb adolescent misuse without limiting adult access, lawmakers should refrain from unnecessary additional barriers. Targeted age controls strike the right balance between safety and availability.

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This Proposed Safety Administrative Order addresses the GRASE status of codeine, codeine phosphate, and codeine sulfate as antitussive active ingredients.

While VOCs can have environmental impacts in aggregate, existing alternatives don’t always provide the consistent therapeutic results needed for OTC products relied upon by millions for. As such, any legislation aimed at further restricting pharmaceutical VOCs must carefully weigh potential unintended consequences on public health.